Risperdal Plaintiffs Seek Release of Johnson & Johnson Study Data

respirdal-plantiffs-seek-release-of-documentsLast week, plaintiffs in a number of product liability lawsuits against Johnson & Johnson (J&J) involving the antipsychotic drug Risperdal, told a Pennsylvania judge that documents describing the medication’s risks are vital to the public interest should not remain under seal.

Nearly 275 product liability lawsuits have been brought against J & J’s Janssen Pharmaceuticals unit, and attorneys for the plaintiffs blasted a motion entered by the drug maker seeking to maintain a 2011 order protecting the confidentiality of a series of clinical studies on Risperdal, Law360 reports.

The plaintiffs’ complaint alleges that Risperdal caused gynecomastia—abnormal growth of breast tissue in adolescent boys—and they argue that the protected material should not be considered proprietary because it consists of observations about the effectiveness and risks of the drug, according to Law360. The brief states that these are “safety documents that require disclosure for the well-being of the public, full and unfettered review by regulatory authorities and the education of healthcare providers who are prescribing this powerful drug.”

In late November Janssen filed a motion claiming that the plaintiffs were improperly seeking public release of a series of clinical studies under seal by the 2011 court order, according to Law360. Janssen argued that the documents were exempt from public review because they were not public records and had not been filed with the court. The plaintiffs’ brief asserts that “Plaintiffs now possess evidence that Janssen systematically under-reported or misrepresented clinically important study results relating to the occurrence of gynecomastia … in the child and adolescent market. However, the discovery that plaintiffs have uncovered is protected behind the shield of the protective order entered in this case.”

Janssen spokeswoman, Pamela Van Housten, told Law360 that the company fully supported the release of clinical trial data when it would help the advancement of science and medicine, but, she said, “We believe these documents should continue to be confidential to protect patient privacy, intellectual property, and scientific integrity.”

Last month, Law360 reports, J&J agreed to pay $2.2 billion to resolve civil and criminal claims under the federal False Claims Act over accusations that the drug maker, through kickbacks to doctors, illegally promoted off-label use of Risperdal and two of its others drugs. While doctors are permitted to prescribe a drug for uses other those for which it was approved, drug makers are not legally permitted to market a drug except for approved uses.

Settlements have been reached in two cases in the first set of Risperdal product liability cases in Pennsylvania court. A second set of cases is scheduled for trial in early June.

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